BD Viper LT software — Class II medical device recall Z-1866-2017
Terminated recall by Bd Diagnostic, reported 2017-04-26. BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems af
| Recall number | Z-1866-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bd Diagnostic, Sparks, MD, United States |
| Recall initiated | 2015-12-14 |
| Classified | 2017-04-19 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2017-04-19 |
| Quantity | 2 |
| Reason classes | potency, software |
| Model numbers | 442947, 443153, 443155, 443156, 443157, 443902 |
Product
BD Viper LT software, version 3.00H
Reason for recall
BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1866-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.